Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-13 @ 5:45 AM
Study NCT ID:
NCT01685502
Status:
COMPLETED
Last Update Posted:
2014-10-20
First Post:
2012-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Special Drug Use Investigation of Glucobay OD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020909', 'term': 'Acarbose'}], 'ancestors': [{'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2289}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-17', 'studyFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2012-09-12', 'lastUpdatePostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Decrease rate of HbA1c', 'timeFrame': 'Up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'up to1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucobay OD', 'Diabetes Mellitus'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy and safety under practical use of Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1 year observation period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Glucobay OD naive diabetics. Patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Glucobay OD naive diabetics. patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.\n\nExclusion Criteria:\n\n* Patients who are contraindicated based on the product label'}, 'identificationModule': {'nctId': 'NCT01685502', 'briefTitle': 'Special Drug Use Investigation of Glucobay OD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Special Drug Use Investigation of Glucobay OD', 'orgStudyIdInfo': {'id': '16517'}, 'secondaryIdInfos': [{'id': 'Glucobay OD', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients treated with Glucobay OD under practical manner', 'interventionNames': ['Drug: Glucobay ODT (Acarbose, BAYG5421)']}], 'interventions': [{'name': 'Glucobay ODT (Acarbose, BAYG5421)', 'type': 'DRUG', 'description': 'Patients treated with Glucobay OD under practical manner', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}